Mindfulness Based Stress Reduction and Post-Stroke Cognition

Stroke Clinical Trial

Official title:

Mindfulness Matters: The Impact of Mindfulness Based Stress Reduction on Post-Stroke Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302493
• Other study ID #: IRB00242665
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators don't fully understand how, regardless of the size or location in the brain, minor strokes can result in significant problems with focus, attention, and multi-tasking that prevent individuals from returning to an active lifestyle, and negatively impact quality of life; but the investigators' preliminary data using magnetoencephalography (MEG) suggest that there may be disruption of the neuronal network and abnormal frontal lobe activity in the brain after stroke. Mindfulness Based Stress Reduction (MBSR) is effective at treating frontal lobe dysfunction in the form of anxiety and depression occurring during the chronic phase of stroke recovery. The aim of this study is to use MBSR to improve other forms of frontal lobe dysfunction (cognitive outcomes) during the subacute phase of recovery, when patients are making critical decisions regarding patients' ability to return to work or live independently; and to use MEG, a tool capable of imaging brain activity and neuronal networks, to understand the brain changes that correspond to improvement after treatment.

Description:

Thrombectomy has significantly improved stroke outcomes. Nearly 80% of the investigators' clinic population now present with small strokes and low NIH Stroke Scale (NIHSS) scores. However, despite "good recoveries", greater than 40% endorse significant problems with concentration, attention, executive function, processing speed, and mood during the subacute phase of recovery. This dysfunction prohibits individuals from fully reintegrating into the individuals' prior home and workplace environments and can result in early retirement or loss of independence, particularly in the older population. Some degree of recovery is observed by 6 months, but it is often incomplete or too late to reverse prior life-altering decisions. The impaired executive function and processing speed appear to occur independent of stroke size, location, or co-existing depression. Magnetoencephalography (MEG) is a functional imaging tool able to evaluate neurophysiologic processes in real time similar to EEG, but with better spatial resolution. The investigators' prior work with MEG suggests that cerebral activation patterns are not only slowed and more dispersed during task completion in individuals with minor stroke compared to controls, but that there is abnormal activity in the frontal lobes, even at rest. Unfortunately, many patients do not qualify for rehabilitation and there is little data regarding effective treatment options to hasten or augment recovery. Mindfulness training may provide an attractive therapeutic option. A combination of meditation, body awareness, and yoga, Mindfulness Based Stress Reduction (MBSR) is an active process thought to engage the frontal lobes. MBSR has been shown to improve anxiety and depression in patients with chronic disease states like migraine and diabetes, and has also been evaluated in a small series of patients with chronic stroke and traumatic brain injury demonstrating improved performance during tasks of executive function. The investigators propose to study the effect of MBSR in the early phase of stroke recovery to determine if this intervention can help to prevent post-stroke morbidity. A cohort of patients [NIHSS <8, modified Rankin Scale (mRS) 0-2] will be enrolled. Half will be randomized to a standard 8 week course of MBSR, while the control group will instead participate in a weekly Stroke Support Group (SSG). Depression, cognition, patient perception of recovery, and degree of re-integration into prior environments will be evaluated pre- and post-intervention to determine the impact of mindfulness training on subacute post-stroke depression and cognition. All participants will undergo neuroimaging using MEG pre- and post-intervention to determine the neurophysiologic effect of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adults (=18 years) presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission).
• Evidence on brain MRI of acute ischemic stroke (imaging negative strokes and transient ischemic attacks (TIAs) will be excluded).
• Native English speaker (by self-report) prior to stroke.
• NIHSS <8 at initial follow-up visit (approximately 30 days post-stroke).
• mRS 0-2 at initial follow-up visit.

Exclusion Criteria:

• Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI.
• Presence of proximal large vessel occlusion.
• Cortical exam findings including aphasia or neglect.
• Prior history of dementia or undertreated psychiatric illness.
• Uncorrected hearing or visual loss.
• Inability to attend weekly MBSR or Stroke Support Group sessions.
• Inability to travel to College Park (UMD) for 2 MEG recording sessions.
• Presence of any of the following that would lead to significant artifact on MEG:

cardiac pacemaker, intracranial clips, metal implants or external clips within 10mm of the head, metal implants in the eyes (unlikely given that all patients will have an MRI and criteria are similar).

• Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG machine for up to 1 hour.

Related Conditions & MeSH terms

• Cognitive Impairment
• Depression
• Stroke
• Stroke Sequelae

Intervention

Behavioral:
• Mindfulness Based Stress Reduction (MBSR)
Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
• Stroke Support Group (SSG)
As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of Maryland, College Park

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chen K, Marsh EB. Chronic post-stroke fatigue: It may no longer be about the stroke itself. Clin Neurol Neurosurg. 2018 Nov;174:192-197. doi: 10.1016/j.clineuro.2018.09.027. Epub 2018 Sep 17. — View Citation

Marsh EB, Lawrence E, Gottesman RF, Llinas RH. The NIH Stroke Scale Has Limited Utility in Accurate Daily Monitoring of Neurologic Status. Neurohospitalist. 2016 Jul;6(3):97-101. doi: 10.1177/1941874415619964. Epub 2015 Dec 13. — View Citation

Marsh EB, Lawrence E, Hillis AE, Chen K, Gottesman RF, Llinas RH. Pre-stroke employment results in better patient-reported outcomes after minor stroke: Short title: Functional outcomes after minor stroke. Clin Neurol Neurosurg. 2018 Feb;165:38-42. doi: 10.1016/j.clineuro.2017.12.020. Epub 2017 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognition as assessed by the Montreal Cognitive Assessment score	The Montreal Cognitive Assessment (MoCA) tests executive function, attention, concentration, memory, and processing speed. The MoCA is scored on a scale of 0-30. Scores of less than 26 are considered abnormal.	At 1 and 6-month visits
Primary	Change in Cerebral Activity as assessed by the amplitude on Magnetoencephalography (MEG)	Participants will undergo an MEG evaluating the amplitude of evoked potentials: 1) during resting state, and 2) during completion of a visual task.	At 1 and 6-month visits
Primary	Change in Cerebral Activity as assessed by the latency on MEG	Participants will undergo an MEG evaluating the latency of evoked potentials: 1) during resting state, and 2) during completion of a visual task.	At 1 and 6-month visits
Primary	Change in Quality of Life as assessed by a Likert scale	Patient-reported assessment of quality of life (Likert scale 1-7) at the 1 and 6 month visits.	At 1 and 6-month visits
Primary	Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)	The PHQ-9 will be administered to participants to evaluate for post-stroke depression. The PHQ-9 is scored on a scale of 0-27 with scores of 5-9 being indicative of mild depression and higher scores more severe depression.	At 1 and 6-month visits
Secondary	Change in anxiety as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) score	A subset of the PROMIS measures will also be administered pre- and post-MBSR to evaluate patient-reported outcomes within the MBSR group. Higher scores indicate more anxiety.	At 1 and 6 months
Secondary	Change in depression as assessed by the PROMIS score	A subset of the PROMIS measures will also be administered pre- and post-MBSR to evaluate patient-reported outcomes within the MBSR group. Higher scores indicate more depression.	At 1 and 6 months
Secondary	Change in fatigue as assessed by the PROMIS score	A subset of the PROMIS measures will also be administered pre- and post-MBSR to evaluate patient-reported outcomes within the MBSR group. Higher scores indicate more fatigue.	At 1 and 6 months
Secondary	Change in Cerebral Connectivity Patterns on MEG	Participants will undergo an MEG evaluating cerebral activity and connectivity patterns using Granger Causality statistics: 1) during resting state, and 2) during completion of a visual task.	At 1 and 6-month visits
Secondary	Ability to Return to Work as assessed by a yes/no questionnaire	The ability to return to work will be assessed (yes/no) at 1 month clinic visit.	1-month visit
Secondary	Ability to Return to Work as assessed by a yes/no questionnaire	The ability to return to work will be assessed (yes/no) at 6 months clinic visit.	6-month visit

External Links

•   Marsh Lab Website